5500/20 Vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)

Last updated: March 11, 2025
Sponsor: British Columbia Cancer Agency
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer, Early, Recurrent

Prostate Cancer

Urologic Cancer

Treatment

Stereotactic body radiotherapy

High dose rate brachytherapy

Permanent seed implant

Clinical Study ID

NCT04610372
H20-01207
  • Ages > 18
  • Male

Study Summary

We will investigate whether ultrahypofractionation using stereotactic ablative radiotherapy (SABR) or brachytherapy is as well-tolerated as moderately hypofractionated external beam radiotherapy (EBRT) for treating the prostate in patients with oligometastatic prostate cancer. Secondary aims include assessment of progression-free survival (PFS) and overall survival (OS) as well as cost-effectiveness. We hypothesize that ultrahypofractionation will maintain favorable toxicity profiles and quality of life while achieving comparable or better efficacy, thereby providing a convenient and cost-effective alternative to moderately hypofractionated EBRT.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Able to provide informed consent

  • European Cooperative Oncology Group performance status 0 to 2

  • Medically fit for all protocol treatment and follow-up

  • Histologically confirmed adenocarcinoma of the prostate

  • Newly diagnosed any Tumor stage, any Nodal stage but with oligo metastases

  • No prior therapy for prostate cancer apart from androgen deprivation

  • Able to complete the necessary investigations prior to randomization (History andphysical examination, PSA)

  • Able to complete the necessary investigations prior to start of Radiotherapy (Transrectal ultrasound-guided biopsy or equivalent, CT chest, abdomen & pelvis orMRI abdomen and pelvis, and Bone scan)

  • Planned for long-term androgen deprivation therapy (greater than 9 months induration)

Exclusion

Exclusion Criteria:

  • High metastatic burden defined as 5 or more bone metastases or visceral metastases

  • Abnormal liver function

  • Contraindications to EBRT such as active inflammatory bowel disease or previouspelvic radiation

  • Medically unfit for anesthesia

  • International Prostate Symptom Score (IPSS) greater than 20

  • Restrictive flow pattern with peak flow rate less than10 mL per second or post-voidresidual greater than 25 per cent of voided volume (when uroflowmetry available)

  • Prostate volume greater than 60cc after maximal cytoreduction

  • Pubic arch interference

  • Transurethral resection of prostate (TURP) within 12 weeks of brachytherapy

Study Design

Total Participants: 168
Treatment Group(s): 4
Primary Treatment: Stereotactic body radiotherapy
Phase:
Study Start date:
July 12, 2021
Estimated Completion Date:
June 30, 2033

Study Description

Men newly diagnosed with low volume oligometastatic prostate cancer defined as fewer than 5 bone metastases and/or non regional lymph node involvement who agree to treatment of the primary cancer with radiation will be randomized between standard moderately hypofractionated external radiotherapy (5500 centiGray/20 fractions as per Stampede trial) and one of 3 alternatives: stereotactic body radiotherapy (SABR) to deliver 36 Gy/5 fractions, or low dose rate Iodine 125 permanent seed implant or a single high dose rate temporary implant. The trial will take place in 4 regional cancer centers of British Columbia Cancer Agency, with each center choosing their preferred alternative to 5500/20. To achieve 4 equally sized treatment arms, each randomization is weighted 3:1 for 42 patients in each arm and 168 total accrual. The primary endpoint is urinary quality of life as assessed by the International Prostate Symptom Score (IPSS) . As the typical acute symptoms from each of these radiation modalities has a unique time course, assessments are done at 6 different points during the first 2 years. Secondary endpoints are global quality of life as assessed by Expanded Prostate Cancer Index (EPIC) urinary, bowel and sexual scores, progression free survival, overall survival and cost effectiveness.

Connect with a study center

  • British Columbia Cancer Agency Center for the Southern Interior

    Kelowna, British Columbia V1Y5L3
    Canada

    Active - Recruiting

  • Fraser Valley Cancer Center

    Surrey, British Columbia
    Canada

    Site Not Available

  • Vancouver Cancer Center

    Vancouver, British Columbia
    Canada

    Site Not Available

  • Vancouver Island Cancer Center

    Victoria, British Columbia
    Canada

    Active - Recruiting

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